4 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1, R560BCS1. Used in cardiopulmonary bypass (CPB) procedures.
FDA Recall
Open, Classified
·Medtronic Perfusion Systems·Product code DWA·March 3, 2021
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CPB ADJUNCT PACK, DR. C PACK, PK CUST CV A&B C CO, TOL DR R PACK, TOL DR. C PACK, TOL DR. M PACK.
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code LRO·February 21, 2025
Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System
FDA Recall
Open, Classified
·Accriva Diagnostics, Inc.·Product code JBP·November 5, 2025
Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
FDA Recall
Open, Classified
·Medtronic Perfusion Systems·Product code JBP·October 20, 2025